Identity
- Trade Name
- RelyX™ Fiber Post 3D FDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- 3M™ ESPE™ RelyX™ Fiber Post 3D Trial Kit/RelyX™ Unicem 2, 56958. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts. FDA UDI
- Model / Reference
- 56958 FDA UDI
- Description
- 3M™ ESPE™ RelyX™ Fiber Post 3D Trial Kit/RelyX™ Unicem 2, 56958. Sterilization prior to use only for RelyX Fiber Post Drills. Do not sterilize either RelyX Unicem 2 Automix nor RelyX Fiber Posts. FDA UDI
Identifiers
- Catalog Number
- 56958 FDA UDI
- Primary DI / UDI-DI
- 04035077010191 FDA UDI
- FDA Product Code
- ELR FDA UDIEMA FDA UDIDZA FDA UDIEID FDA UDI
- GMDN Term
- Dental material mixing nozzle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3810 FDA UDI872.3275 FDA UDI872.4130 FDA UDI872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental composite resinDental material injection cannula, single-useRoot canal post, preformedDental material mixing nozzle
RelyX™ Fiber Post 3D by 3M Deutschland GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental material mixing nozzle.
- Adhesive Tip Applicator — Huanghua Promisee Dental Co.Ltd. · Class I
- 3.2 Mixing Tips with Integrated Needle 25-Pack — Den-Mat Holdings, LLC · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- #1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
- Plasdent — PLASDENT CORP. · Class I
- BL-42A — Zhaoqing Gaoyao Recende Medical Equipment Co.,LTD · Class I
- Britedent — BRIGHT SUPPLY INC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3M Deutschland GmbH
Sources (1)
- FDA UDI 6f89f817-5ea3-4e13-a6bc-659da95b935a 36 fields · synced May 30, 2026